Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Pimecrolimus; Tacrolimus

Criteria

Inclusion Criteria:

• History of artificial tear use

• Moderate to severe signs of dry eye

• Moderate to severe ocular discomfort

Exclusion Criteria:

• Patients with uncontrolled systemic or ocular diseases.

• Have any history of refractive surgery

• Use any topical ocular medications other than those dispensed for the study, during the study

Other protocol-defined exclusion criteria may apply.